HealthyLIPOGAINNCT01427140
Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN)
A study testing Polyunsaturated fatty acid group and Saturated fatty acid group in people with Healthy, run by Uppsala University at 1 site in Sweden.
Trial summary
The purpose of this study is to investigate the metabolic consequences of a moderate weight gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects in young healthy adults. Hypothesis: the type of dietary fat can modify the effects of weight gain. Read more about this study
- Who is it for?
- Ages 20 to 38 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Polyunsaturated fatty acid group and Saturated fatty acid group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 38 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy,
- Body Mass Index 18-27
Who cannot join
- Liver disease,
- Coronary heart disease,
- Diabetes mellitus,
- Malignant diseases,
- Alcohol or drug abuse,
- Magnetic Resonance-incompatibility,
Show all 11Show fewer
- Abnormal clinical chemistry,
- Use of drugs that significantly effects energy metabolism,
- Heavy exercise,
- Pregnancy or lactation,
- Allergy of gluten, egg or milk protein
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN): a Randomized Double-Blind Controlled Study
The purpose of this study is to investigate the metabolic consequences of a moderate weight gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects in young healthy adults. Hypothesis: the type of dietary fat can modify the effects of weight gain.
Read the detailed description
Specific goals:
- Investigate if dietary fat composition influences liver fat accumulation and metabolic risk factors in response to moderate weight gain
- Investigate if polyunsaturated fat (PUFA) in the diet could counteract any unfavorable metabolic changes that are expected to accompany moderate weight gain
- Investigate effects of weight gain and dietary fat composition on markers of vascular health
- Conditions
- Healthy
- Being tested
- Polyunsaturated fatty acid group, Saturated fatty acid group
- Keywords
- Liver fat, Polyunsaturated fatty acids (PUFA), Saturated fatty acids (SFA), Weight gain, Overfeed, Dietary fatty acids, Palm oil, Sunflower oil
- Medical subject headings
- Fatty Liver, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyunsaturated fatty acid groupOther
Addition of polyunsaturated fatty acids to the diet in the form of pastries
Saturated fatty acid groupOther
Addition of saturated fatty acids to the diet in the form of pastries
| Study group | Role | What they receive |
|---|---|---|
| Saturated fatty acid group | Active comparator | Addition of saturated fatty acids to the diet inte the form of pastries Receives: Other: Saturated fatty acid group |
| Polyunsaturated fatty acid group | Active comparator | Addition of polyunsaturated fatty acids to the diet in the form of pastries Receives: Other: Polyunsaturated fatty acid group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic steatosis by magnetic resonance tomography (MRT)
Measured: 6 weeks
Secondary outcomes (20)
high density lipoprotein (HDL)
Measured: 6 weeks
low density lipoprotein (LDL)
Measured: 6 weeks
Insulin
Measured: 6 weeks
Glucose
Measured: 6 weeks
Triglycerides
Measured: 6 weeks
Cholesterol
Measured: 6 weeks
Apolipoprotein B (ApoB)
Measured: 6 weeks
Apolipoprotein A1 (ApoA1)
Measured: 6 weeks
Aspartate aminotransferase (ASAT)
Measured: 6 weeks
Alanine aminotransferase (ALAT)
Measured: 6 weeks
Gamma glutamyl transpeptidase (GGT)
Measured: 6 weeks
Homeostasis model of assessment insulin resistance (HOMA-IR)
Measured: 6 weeks
C-reactive protein (CRP)
Measured: 6 weeks
Proinsulin
Measured: 6 weeks
Endostatin
Measured: 6 weeks
Pentraxin-3 (PTX-3)
Measured: 6 weeks
Endothelin-1 (ET-1)
Measured: 6 weeks
E-selectin
Measured: 6 weeks
Cathepsin-S
Measured: 6 weeks
Cystatin C
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulf Risérus, Ass. professor, Principal investigator, Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01427140
- Sponsor's protocol ID
- SLS-2011-LPG
- Acronym
- LIPOGAIN
- Status last verified
- Dec 2011
- First submitted
- 19 Aug 2011
- Last updated
- 9 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosqvist F, Orho-Melander M, Kullberg J, Iggman D, Johansson HE, Cedernaes J, Ahlstrom H, Riserus U. Abdominal Fat and Metabolic Health Markers but Not PNPLA3 Genotype Predicts Liver Fat Accumulation in Response to Excess Intake of Energy and Saturated Fat in Healthy Individuals. Front Nutr. 2020 Dec 3;7:606004. doi: 10.3389/fnut.2020.606004. eCollection 2020.
PubMed 33344496Perfilyev A, Dahlman I, Gillberg L, Rosqvist F, Iggman D, Volkov P, Nilsson E, Riserus U, Ling C. Impact of polyunsaturated and saturated fat overfeeding on the DNA-methylation pattern in human adipose tissue: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):991-1000. doi: 10.3945/ajcn.116.143164. Epub 2017 Mar 8.
PubMed 28275132Iggman D, Rosqvist F, Larsson A, Arnlov J, Beckman L, Rudling M, Riserus U. Role of dietary fats in modulating cardiometabolic risk during moderate weight gain: a randomized double-blind overfeeding trial (LIPOGAIN study). J Am Heart Assoc. 2014 Oct 15;3(5):e001095. doi: 10.1161/JAHA.114.001095.
PubMed 25319187
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN): a Randomized Double-Blind Controlled Study
- ClinicalTrials.gov ID
- NCT01427140
- Acronym / sponsor ID
- LIPOGAIN / SLS-2011-LPG
- Conditions
- Healthy
- Keywords
- Liver fat, Polyunsaturated fatty acids (PUFA), Saturated fatty acids (SFA), Weight gain, Overfeed, Dietary fatty acids, Palm oil, Sunflower oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 1 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the metabolic consequences of a moderate weight gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects in young healthy adults. Hypothesis: the type of dietary fat can modify the effects of weight gain.
Detailed description
Specific goals:
- Investigate if dietary fat composition influences liver fat accumulation and metabolic risk factors in response to moderate weight gain
- Investigate if polyunsaturated fat (PUFA) in the diet could counteract any unfavorable metabolic changes that are expected to accompany moderate weight gain
- Investigate effects of weight gain and dietary fat composition on markers of vascular health
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saturated fatty acid group | Active comparator | Other: Saturated fatty acid groupAddition of saturated fatty acids to the diet inte the form of pastries |
| Polyunsaturated fatty acid group | Active comparator | Other: Polyunsaturated fatty acid groupAddition of polyunsaturated fatty acids to the diet in the form of pastries |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy,
- Body Mass Index 18-27
Key exclusion criteria (11 listed)
- Liver disease,
- Coronary heart disease,
- Diabetes mellitus,
- Malignant diseases,
- Alcohol or drug abuse,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyunsaturated fatty acid groupAddition of polyunsaturated fatty acids to the diet in the form of pastries | Other | Polyunsaturated fatty acid group |
| Saturated fatty acid groupAddition of saturated fatty acids to the diet in the form of pastries | Other | Saturated fatty acid group |
Primary outcome
Hepatic steatosis by magnetic resonance tomography (MRT)
Time frame: 6 weeks
20 secondary outcomes
high density lipoprotein (HDL)
Time frame: 6 weeks
low density lipoprotein (LDL)
Time frame: 6 weeks
Insulin
Time frame: 6 weeks
Glucose
Time frame: 6 weeks
Triglycerides
Time frame: 6 weeks
Cholesterol
Time frame: 6 weeks
Apolipoprotein B (ApoB)
Time frame: 6 weeks
Apolipoprotein A1 (ApoA1)
Time frame: 6 weeks
Aspartate aminotransferase (ASAT)
Time frame: 6 weeks
Alanine aminotransferase (ALAT)
Time frame: 6 weeks
Gamma glutamyl transpeptidase (GGT)
Time frame: 6 weeks
Homeostasis model of assessment insulin resistance (HOMA-IR)
Time frame: 6 weeks
C-reactive protein (CRP)
Time frame: 6 weeks
Proinsulin
Time frame: 6 weeks
Endostatin
Time frame: 6 weeks
Pentraxin-3 (PTX-3)
Time frame: 6 weeks
Endothelin-1 (ET-1)
Time frame: 6 weeks
E-selectin
Time frame: 6 weeks
Cathepsin-S
Time frame: 6 weeks
Cystatin C
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2011.
- Derived from this study: PubMed 33344496Rosqvist F, Orho-Melander M, Kullberg J, Iggman D, Johansson HE, Cedernaes J, Ahlstrom H, Riserus U. Abdominal Fat and Metabolic Health Markers but Not PNPLA3 Genotype Predicts Liver Fat Accumulation in Response to Excess Intake of Energy and Saturated Fat in Healthy Individuals. Front Nutr. 2020 Dec 3;7:606004. doi: 10.3389/fnut.2020.606004. eCollection 2020.
- Derived from this study: PubMed 28275132Perfilyev A, Dahlman I, Gillberg L, Rosqvist F, Iggman D, Volkov P, Nilsson E, Riserus U, Ling C. Impact of polyunsaturated and saturated fat overfeeding on the DNA-methylation pattern in human adipose tissue: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):991-1000. doi: 10.3945/ajcn.116.143164. Epub 2017 Mar 8.
- Derived from this study: PubMed 25319187Iggman D, Rosqvist F, Larsson A, Arnlov J, Beckman L, Rudling M, Riserus U. Role of dietary fats in modulating cardiometabolic risk during moderate weight gain: a randomized double-blind overfeeding trial (LIPOGAIN study). J Am Heart Assoc. 2014 Oct 15;3(5):e001095. doi: 10.1161/JAHA.114.001095.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ulf Risérus, Ass. professor principal investigator
Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyunsaturated fatty acid group and Saturated fatty acid group in people with Healthy, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic steatosis by magnetic resonance tomography (MRT) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01427140, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2011.